跳至主要内容
临床试验/NCT04062864
NCT04062864已完成不适用

Validity of Pupil Diameter for Pain Monitoring During General Anesthesia in Children : a Prospective Observational Study

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Pupil diameter

研究概览

简要总结

This study evaluates the validity of pupil diameter as an indicator of pain during surgery under general anesthesia.

详细描述

Pupil diameter is known to be strongly correlated with sympathetic tone. During surgery under general anesthesia, there is no standardized means of pain assessment. As pain activates sympathetic nervous system, we hypothesized that pupil diameter can be a marker for pain during surgery.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children undergoing surgery under general anesthesia with total time of less than two hours

排除标准

  • Children whose parent or legal guardian declined to enroll
  • Any use of opioids during surgery
  • History of hypersensitivity to any anesthetic agents
  • Any medication that can affect sympathetic nervous activity
  • Presence of underlying ophthalmologic disease

结局指标

主要结局

Pupil diameter

时间窗: From start of anesthesia to end of anesthesia

Pupil diameter before and after painful stimuli (skin incision, train-of-four stimulation)

次要结局

  • Bispectral index(From start of anesthesia to end of anesthesia)
  • Pleth variability index(From start of anesthesia to end of anesthesia)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hee-Soo Kim

Professor

Seoul National University Hospital

研究点 (1)

Loading locations...

相似试验

Pupillometer as a Pain Index During General... | 临床试验